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Pharmaceutical products storage temperature

Q1 The refrigerator in the pharmacy that is used for storage of pharmaceutical products should be kept at a temperature of ... [Pg.89]

Temperature, relative humidity and ventilation should be appropriate and should not adversely affect the quality of pharmaceutical products during their manufacture and storage, or the accurate functioning of equipment. [Pg.46]

Storage areas should be designed or adapted to ensure good storage conditions. In particular, they should be clean and dry and maintained within acceptable temperature limits. Pharmaceutical products should be stored off the floor and suitably spaced to permit cleaning and inspection. Pallets should be kept in a good state of cleanliness and repair. [Pg.189]

Activation energy is usually estimated from the accelerated stability data. However, when the activation energy is known, the degradation rate at storage temperature may be predicted from data collected at only one elevated temperature. This practice is sometimes preferred in the industry as it reduces the size and time of accelerated stability tests. Experience indicates that some pharmaceutical analytes have activation energies in the range of 10-20 kcal/mol, but it is unlikely you will have precise information or be able to make assumptions about the activation energy of a certain product. [Pg.304]

Photochemical reactivity of drug formulations is an important aspect to consider during development, production, storage, and use of pharmaceutical preparations. However, photochemical stability of drug substances is rarely as well documented as thermal stability of the compounds. For instance, in order to obtain a high sterility assurance level of the product, a parenteral preparation is sterilized in its final container if possible. Steam sterilization at minimum temperature of 121°C for... [Pg.303]

O. L. Davies and D. A. Budgett, Accelerated storage tests on pharmaceutical products Effect of error structure of assay and errors in recorded temperature, J. Pharm. Pharmacol. 32, 155-159(1980). [Pg.239]

Long-term stability testing for countries in Climatic Zones II is recommended to be conducted at 25°C/60% RH, whereas storage temperatures of pharmaceutical products in pharmacies according to the USP may fluctuate between 15 and 30°C. [Pg.36]


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See also in sourсe #XX -- [ Pg.364 ]




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